Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-08

Study Completion Date

2025-03-31

Brief Summary

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The multicenter, prospective, observational, non-interventional study conducted in German Stroke Units is investigating patients with intracranial hemorrhage (ICH) under effective anticoagulation with rivaroxaban or apixaban.

The aim of the study is to analyze under routine conditions wether the volume increase of ICH under treatment with rivaroxaban and apixaban can be reduced with the antidote andexanet alfa. Thus, data of patients under effective treatment with rivaroxaban or apixaban and treated with andexanet alfa at baseline will be assessed at the time of onset of ICH, during the hospital stay and during a follow-up by telephone at 30 and 90 days after hospital discharge.

The main objective is defined as the change in size or volume of the hematoma by computed tomography (CT) or magnetic resonance imaging (MRI) in patients with ICH under effective treatment with rivaroxaban and apixaban, who are treated with andexanet alfa. Further objectives comprise evaluations concerning the functional status according to modified Rankin Scale (mRS), changes in the National Institutes of Health Stroke Scale (NIHSS), and occurrences of ICH or new intraventricular bleeding as well as mortality rates.

Detailed Description

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Conditions

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Intracranial Hemorrhages

Keywords

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Intracranial bleeding Andexanet-alfa Rivaroxaban Apixaban Anticoagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient group

Patients under effective anticoagulation with rivaroxaban or apixaban and treated with andexanet alfa

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years at enrollment
* Patients willing and able to provide written informed consent for data transmission. For patients who are not legally competent to sign this informed consent for data transmission exceptions/special cases are defined (details provided in the study protocol)
* Patients with primary intracranial hemorrhage as confirmed with CT or MRI.
* Patients under effective anticoagulation treatment with rivaroxaban or apixaban at the time of admission, according to the judgement of treating physician and determined using Point-of-care (PoC) anti-factor Xa (fXa) assays or laboratory-based anti-fXa measurement.
* Patients treated with andexanet alfa
* Signed informed consent as soon as possible after start of symptoms of initial ICH event, but before discharge

Exclusion Criteria

* Start of symptoms of initial ICH event \> 24 h before admission to hospital

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Prof. Dr. Hans Diener

Senior Professor of Clinical Neurosciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans Diener, Prof. Dr.

Role: STUDY_DIRECTOR

University Hospital, Essen

Locations

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Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Universitätsklinikum Tübingen

Tübingen, , Germany